1. Field of the Invention
The present invention relates to invasive methods and devices which position and anchor single or multiple lumen catheters proximate to breast lesions under radiographic guidance in order to provide a conduit or conduits for reversible placement of devices such as an optical fiber or allow the delivery of medicament or drug solutions such as anesthetic to sites in breast tissue along the length of the catheter.
2. Background of the Invention
There is an abundance of published literature surrounding wire needle localization (WNL) and its use in breast biopsy. Specifically, WNL is a surgical technique frequently invoked by surgeons to biopsy lesions in the breast discovered as a result of mammography or other breast screening methods. Patients undergoing WNL are placed on a radiographic table usually located in the radiology suite. The breast is placed between two compression plates, arranged moveably in relation to one another, for fixing the breast there between. The compression plates have holes which permit the introduction of a biopsy needle under radiographic guidance into the breast and proximate to the breast lesion to be biopsied. Once the needle is placed in the desired position in the breast, a thin, stiff wire with a distal retaining hook is inserted through the lumen of the needle. As the wire emerges from the distal aspect of the needle, the distal hook of the wire engages the breast tissue proximate to the breast lesion. The needle is withdrawn leaving the hook wire proximate to the lesion. The position of the wire relative to the lesion is verified radiographically. Radiographic views of the wire in the breast are taken and brought to the operating room so as to allow the surgeon to plan the surgical biopsy procedure.
The patient is transferred to the operating room. After physically examining the breast and placement of the wire in the breast as well as the radiographs of the wire placement, the surgeon plans the surgical approach for the removal of the desired breast tissue specimen. The wire serves as a marker which can be palpated by the surgeon during surgery. Using a typical syringe and needle, local anesthetic is administered in and around the proposed surgical area. An incision is made and the surgeon dissects around the wire. During the dissection, the surgeon continuously palpates the location of the wire in order to orient the dissection and determine that amount of tissue to be harvested or biopsied. The surgical objective of the biopsy is to remove an adequate tissue sample such that the wire and the lesion are at the center of the sample surrounded by an adequate margin thickness of normal breast tissue.
In U.S. Pat. No. 5,782,771 entitled xe2x80x9cDual, Fused, and Grooved Optical Localization Fibers,xe2x80x9d Hussman discloses the use of an optical fiber or bundle of optical fibers with a hook fixed to the distal aspect of the optical fiber or fiber bundle. The optical fiber-hook assembly can be passed through the lumen of a needle. As the optical fiber-hook assembly exits the needle and enters the breast tissue, the hook engages the tissue thus anchoring the optical fiber-hook assembly within the breast tissue. The other end of the optic fiber or fiber bundle can be connected to a light source. Light traverses the length of the optical fiber and transilluminates breast tissue and exits at the distal end of the optical fiber. The optical fiber enables the surgeon to identify the tip of the optical fiber by the light which originates from a light source such as a 15 mW 635 nm red laser diode. The tip of the optical fiber can be detected with the eye (since the eye is sensitive to 635 nm) if the tissue overlying permits ample light transmission for the eye to detect. If the tip of the optical fiber is buried deep in breast tissue and not visible to the eye, then a probe fabricated from optical fiber is invasively inserted into the breast. When the probe tip is maneuvered to a location near the fiber tip emitting light, the probe tip captures lights departing from the fiber tip. Light is transmitted along the length of the probe and exits the probe and incident upon the eye. The eye may detect light emanating from the distal end of the prove if sufficient light is emitted by the optical tip and transmitted to the eye via the probe. The operating room lights may have to be dimmed in order to improve performance of the Hussman technique.
Optically, all biological tissues are considered composite structures consisting of a scattering medium imbibed with various molecular components which collectively absorb or scatter light at specific wavelengths, i.e. the body is a spectral filter that selectively scatters or absorbs electromagnetic energy as a function of wavelength. In the range of 200 nm to 1,500 nm, the amount of light absorbed or scattered by different molecules is dependent on the chemical and physical properties of the molecule. In the visible part of the electromagnetic spectrum (400 nm to 700 nm), absorption due to tissues and tissue components coupled with light loss caused by scattering results in varying transmissivity of visible light through tissue. In the infrared spectrum above 1,300 nm, water present in tissue acts as an effective absorber of infrared, again limiting the transmission of infrared wavelengths longer than 1,300 nm. However, in the infrared range of 700 to 1,300 nm, infrared light has a relatively high transmissivity compared to visible light. This window of transmissivity (a measure of light transmission) is due to the lack of molecular components that strongly absorb infrared between 700 nm and 1,300 nm.
Fontenot, in U.S. Pat. No. 5,423,321 entitled xe2x80x9cDetection of Anatomic Passages Using Infrared Emitting Fiber,xe2x80x9d describes a method and devices which take advantage of the body""s inherently high light transmissivity in the near infrared range (700 nm to 1,300 nm). U.S. Pat. No. 5,423,321 describes intraluminal infrared transillumination of natural passages in the body such as the ureter which is a duct connecting the kidney to the bladder. A ureteral catheter enters the body through natural passages, specifically the vaginal orifice first, then the lumen of the urethra, bladder, and into the lumen of the ureter with the aid of a cystoscope. A plastic fiberoptic light guide is fitted into the lumen of the ureteral catheter and coupled to an infrared laser diode. Infrared laser light transilluminating the ureter and overlying tissues is detected with either a video system sensitive to near infrared or a detector probe coupled to a photodetector that is also sensitive to infrared.
As previously discussed, Hussman, in U.S. Pat. No. 5,782,771, describes a novel method and device for anchoring an optical fiber in breast tissue. However, fixing anchoring devices to the tip of optical fibers can weaken or embrittle the fibers causing the fiber to break in tissue while residing in the body. Also, in U.S. Pat. No. 5,782,771, Hussman uses visible light to transilluminate tissue overlying the tip of the optical fiber. Visible light is strongly attenuated by tissues. Thus, to detect the fiber tip emitting visible light in breast tissue and overlying skin, Hussman invasively introduces a probe consisting of a fiber or fiber bundle. The probe is directed towards the fiber tip which is emitting light. Subsequently, light captured by the distal end of the fiberoptic probe travels the length of the probe and exits the opposite end. The human eye may detect the emitted light from the probe if the room lights are dimmed and adequate light is transmitted from the tip of the optical fiber emitting light to the eye through the probe. Hussman does not discuss or present methods or devices that would allow the following: (1) the use of non-invasive methods and devices to detect the fiber tip such as the use of infrared emission-detection techniques, (2) the use of a conduit or catheter that could be fixed or anchor in tissue which would facilitate the reversible placement of a fiberoptic light guide into the lumen of a catheter.
Also, as previously discussed, Fontenot in U.S. Pat. No. 5,423,321, uses a non-anchoring catheter that enters the body through natural passages. For example, to enter the ureter in a female, a cystoscope is introduced into the vagina and into the lumen of the urethra, bladder, and into the lumen of the ureter. The ureteral catheter is then placed in the ureter and the cystoscope retracted. Fontenot transilluminates the natural passage using an emitting fiber and an infrared light source. Detection of the passage is facilitated with a detector probe or video system, both of which are sensitive to infrared light since the human eye cannot detect near infrared. Fontenot does not discuss or present methods or devices that would allow the following: (1) placement of a catheter that is fixed or anchored to the tissue using devices such as a hook wire at the distal aspect of the catheter, (2) placement of the catheter under radiographic guidance, (3) an over the wire method used to guide the catheter to a desired location, and (4) the invasive placement of catheter into tissue or an organ that is not through a natural passage.
It is an object of this invention to invasively insert a catheter under radiographic guidance into the breast and proximate to a breast lesion that forms a conduit for reversible placement of devices such as an emitting fiber or allow medicament or drug solutions such as anesthetic solutions to be delivered to sites in breast tissue along the length of the catheter.
It is another object of the present invention to invasively insert a catheter using an over the wire method, such wire that has been previously placed under radiographic guidance, thus forming a conduit for the reversible placement of devices such as an emitting fiber or allow medicament or drug solutions such as anesthetic solutions to be deliver to sites in breast tissue along the length of the catheter.
In accordance with another embodiment, a catheter with a wire hook or balloon can be fabricated or attached to the distal aspect of the catheter which functions to retain or anchor the catheter in breast tissue.
In yet another embodiment, an emission-detection is used to detect the tip of the catheter in breast tissue or track the course of the catheter in breast tissue.
The present invention relates to invasive placement of single or multi-lumen catheters in the breast tissue under radiographic guidance for the purposes of providing at least: (1) a landmark within the breast and adjacent to a target breast lesion, (2) a conduit for devices such as an optical fiber, (3) a conduit for the delivery of solutions containing medicaments or drugs to site in the breast along the length of the catheter, and (4) a means for anchoring such catheter in breast tissue. More specifically, the present invention consists of a catheter that can be fixed or anchored in breast tissue and provide a conduit for reversibly placing devices such as fiberoptic light guide into a desired position in the lumen of the catheter. The catheter has a means for anchoring the distal end of the catheter and such catheter can be placed proximate to a breast lesion under radiographic guidance. Exemplary means for anchoring catheters include mechanical devices, such as a hook wire or, an expansible anchor (e.g. a mallecott structure), an inflatable balloon formed at the distal end of the catheter. In one embodiment, an over the wire method is used to place a catheter proximate to a breast lesion. To aid in breast dissection and orientation, a visible or infrared light emission-detection scheme is used to detect the tip of the catheter or the course of the catheter as it tracks through breast tissue and exits the breast is also embodied in the invention.